BORTEZOMIB JUNO bortezomib 3.5 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bortezomib, Quantity: 3.5 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: nitrogen; mannitol

Administration route:

Intravenous, Subcutaneous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BORTEZOMIB JUNO (bortezomib 1 mg and 3.5 mg powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,BORTEZOMIB JUNO (bortezomib 1 mg and 3.5 mg powder for injection), as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,BORTEZOMIB JUNO (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,BORTEZOMIB JUNO (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Product summary:

Visual Identification: White to off-white, cake or powder in a glass vial with rubber stopper and flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-04-12

Patient Information leaflet

Bortezomib Juno
BORTEZOMIB JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BORTEZOMIB JUNO?
Bortezomib Juno contains the active ingredient bortezomib. Bortezomib
Juno is used to treat adults with multiple myeloma
(cancer of the bone marrow). Bortezomib Juno is also used for the
treatment of mantle cell lymphoma (a type of cancer affecting
the lymph nodes) in adults in combination with the medicines
rituximab, cyclophosphamide, doxorubicin and prednisone, for
patients whose disease has not been previously treated.
For more information, see Section 1. Why am I using Bortezomib Juno?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB JUNO?
Do not use if you have ever had an allergic reaction to bortezomib or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Bortezomib Juno?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bortezomib Juno and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BORTEZOMIB JUNO?
• Your doctor will decide what dose you will receive. The dose will
be calculated from your height and weight, as well as
factors such as kidney function, liver function and other medicines
you are being given.
• The doctor will determine the number of cycles of treatment also.
More instructions can be found in Section 4. How do I use Bortezomib
Juno?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BORTEZOMIB JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
bortezomib.
•
Keep all doctor’s appointments and follow doctor’s instruction.
You may need

Summary of Product characteristics

Australian Product Information
Page | 1
BORTEZOMIB JUNO POWDER FOR INJECTION
_(BORTEZOMIB)_
_ _
PRODUCT INFORMATION
_ _
1 NAME OF THE MEDICINE
Bortezomib Juno contains bortezomib.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bortezomib Juno (bortezomib) is an antineoplastic agent for
intravenous injection (IV) or
subcutaneous (SC) use only. Each single dose vial contains:
•
1 mg of bortezomib as a sterile lyophilised powder. Inactive
ingredients: 10 mg mannitol
and nitrogen qs, or
•
2.5 mg of bortezomib as a sterile lyophilised powder. Inactive
ingredients: 25 mg mannitol
and nitrogen qs, or
•
3.5 mg of bortezomib as a sterile lyophilised powder. Inactive
ingredients: 35 mg mannitol
and nitrogen qs.
Bortezomib is a modified dipeptidyl boronic acid. The product is
provided as a mannitol
boronic ester which, in reconstituted form, consists of the mannitol
ester in equilibrium with its
hydrolysis product, the monomeric boronic acid. The drug substance
exists in its cyclic
anhydride form as a trimeric boroxine.
The solubility of bortezomib, as the monomeric boronic acid, in water
is: 3.3 – 3.8 mg/mL in a
pH range of 2 – 6.5.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Bortezomib, 1mg, powder for injection.
Bortezomib, 2.5 mg, powder for injection.
Bortezomib, 3.5 mg, powder for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Juno, in combination with melphalan and prednisone is
indicated for the treatment
of patients with previously untreated multiple myeloma who are not
candidates for high dose
chemotherapy.
Bortezomib Juno, as part of combination therapy, is indicated for
induction therapy prior to
high dose chemotherapy with autologous stem cell rescue for patients
under 65 years of age
with previously untreated multiple myeloma.
Bortezomib Juno is also indicated for the treatment of multiple
myeloma patients who have
received at least one prior therapy, and who have progressive disease.
Bortezomib
Juno
in
combination
with
rituximab,